USPTO Patents Application 09870801

Fish &. Richardson p.c.

Ficdertck P. FUh

BOSTON

NEW YOAK
SAN prEGO

yrticoK valle:v

TVIK CITIE5
WAiHlHCTOJ4» DC

500 /Vgucllo Sircci
Suite 500

Rcciwood Ciry, Caitfomia
940^3-1526

Telephone
650 839-5070

Facsimile
^50 83$h507i

WebSite
www.fi.com

BY FAX AND MAIL

March 29, 2002

Perry Clark, Esq.
Weil, Gotshal & Manges LLP
201 Redwood Shores Parkway
Redwood Shores, CA 94065

Re Arthrocare Suit - Delaware

USDC-D; Del. ^ G. A. No. 01-5G4^SLR

Dear Perry:

Pursuant to the discussion during the discovery conference, I have enclosed 5mith &
Nephew's supplemental rioninfri and invalidity responses, which are subject

to and made without waiving Smith & Nephew^s previous objections to ArthroCare's
discovery requests. We resferve the right to revise these responscjs as discovery
proceeds. Ib particular, we reserve the right to revise these responses afterwe have
rieceiVed me^irigfuJ discovery on ArthroCare^s claim cohstructiori and infringement
contentions, arid after the Gourt has construed the asserted claims.

Smith & Nephew objects to ArthroCare's improper attempts to informally amend its
infringement allegations. Our responses concern (1) theDyonics Control RF System
which is the only prbduot alleged in ArthroCare ■ s Complaint to infringe and (2) the
asserted claims priginaUy identified in Jared B6brow*s November 2, 2001 letter. We
are not providihg rfe^p^^ at this time for the additional claims listed in ydur March
1 5 letter since that was the first notice we reeeiyed, jiiSt two weeks ago, that those
claims were beftig asserted. We are ixi the protests of preparing responses to those
additional claimsfy however, and expect to have them to you within the next two
weeks.

In addition, and in response to your letter of March 27,2002, we are also not
providing responses at for the Dyonics Electrpblade Resector

("Eleciroblade") since it is not in the case. As you know, Electroblade was not
accused in ArthroCare ^s Complaint. The only product ArthroCare accuised in its
Complaint Was the Dyonics Control RF System. Further, ArthroCare failed to move
to amend its Cbmplaint as it is required to do under the Rul<^, and the deadline for
amending pl&adihgs in this case expired on March 8, 2002. Instead^ ArthroCare
merely stated in a letter a week later that "Electroblade is now among the accused
products:'*

As you kiipw^^^the accu$ation of infringement in a patent lav^fsuit is a fdfmal step in the
case that carries with it certain burdens to investigate undCT Rule J 1 . Ju<im v, Umied

Fish & R.jhardson p.c.

Perry Clark, Esq,
March !29, 2002
Page 2

States, 1 1 0 F.3d 780 (Fed. Cin 1997); Antonious v. Spalding & Ev€nflo Compmies,
Inc., 275 FJd 1066 (Fed, Cir. 2002). Indeed, in light of ArthroCare-s argument
during the discovery conference on March 5 that it needed discovery to determine
wheither^^ EleclrobJade infringes, we were quite siirprised that Electroblade was
included in ArthroCare's infringement chiart. Accordingly, w^ qii^tion whether
ArthroCare can meet its burden under Rule 11 with respect to Elextroblade.

Please let me know if you are in disagjreenient with any of the foregoing.

Very truly yours,
Keith Walter

South & Nepheiv^s Supplemental Response Re Non-Infringement

IflGHLY CONFIDENTIAL - ATTORNEYS' EYES ONLY

1

2. TJ.S. Patent No. 5,697,882 ("the '882 patent")

IliDACTED

toGBiV GiONl^^ - A1TC)R]SEM* fe^^ES ONLY

2

REDACTED

iSjiGWLY CQNFIDENTIAL - ATTORNEYiS' EYES ONLY

■3-

Smith & Nephew's Supplemental Resp(>n$e Re Invalidity

In addition to its previous objections, and without waiving any of those
objections. Smith Nephew also objects to providing its invalidity contentions at this
tinie, since ArthroCare has refused to provide ahy of its contentions with respect to
construction of the claims of its patents. Accordingly, Smith & Nephew reserves the
right to supplement, amend, or othenvise modify its invalidity contentions as the case
proceeds, and particularly afier ArfhroGaie provides^ proposed elaim construction
and^or after the Court constru^^^ of ArthrtOaie 's^

Neverthelesis, as of the present time, Snxith & Niephew incoipprates its previous
responses by reference, and Jurther iiesj>pnds as follows:

Certain of Smith & Ngjhew- s inyaiidity contentipiis ^e baseid on invalidity under
35 U:S;C § 102 and/of § 1 03 in view of certain prior art references: In the interest of
brevity and conveniencei rather than repeat the full names of those: refexe
cortttejetioji with each such cohterition,^ Smiih & Nephew will instead refer to those
referfeneeB by nimiber, in accordah^^ the following table:

M

Sssnef

FMent Number/
iSiblicatioji

luyentor/AutHof

Title

■ : ^

08/16/33

iUS2i056^77

F;e. Wappler

E)ectix)fficr Itistiiunernt

2

05/00/69

EfigineeriMg 206-
216

A.K. Pobbie

Th^ Eleetiiqal Aglets of
Siirgiical Biiathermy

■^r ■

tiiS/lJ/74

US 3,815,604

Conor C.G'Malley,
I^jphM- HeiijtZiSr.

Ajp0mtJ£$.Fdf Intrapcular
Stf?g.ety

4 '

08/13/74

US 3,828,780

Cjiia^Ifesi^. Morrison,
jr.

(!.'0in^iii^ ElectrocoaguJatdr-
StiCtix^nlaSliQU^

■ 6 '

01/00/75

Transactions On

Biomedical

Efigineefing

William M. Homg

The Mechamsro of Cutting in
Electrosurgefy

1

it

Issue/
Pub'n
Date

Patent Nuidber/
Piiblicatibn'

Inventor/Autbor

Title

6

omens

US 3,901,242

Kiarl Storz

Electric Surgical Instrument

7

H/18/75

US 3,920,021

Siegfried Hiltebrandt .

Coagulating Devices

«

p

vU/UU/ 70

Acta

Medicotechnica
(Mifedianalr
MaifctJi Vol. 24i
Np.4, 1976 129-
134

E. Elsasser and E,
Rods

Uber ein Instrument zur
leckstromfreien triansurethralen
Resettion (Goncerriing; An
Instilment fo^ Trsinsurethral
resection vwthout leakage of
current)

9

yS 3^939*839

Lawrence E, Curtiss

JleseCtoscope and Electrode
Therefpr

10

Q1/2Q/76

us 3*970^088

Charles F, Morrison

tdectrositf giGid jy

Having Sesquipolar Electrode

Stnicturjes Incorporated

Therein

11

01/07/77

2 313 949/
N 76 17587

Sicgjfeed Hiltebra^
etLudwig Bonnet

idiouGle de sectjoxinement a nne
ousdeux branches
resertoseppe

I?

00/00/7&

YblV74,HOv3,
527-534, 1978

Piercey^ M±>.,
D.C. Authi Ph.D,
RE., RE. Silverstein,

M:a, H SL wiii^^^

VihD, M JB. I>enniSi

D.yM,i);M.

eiefson, B.S./D
Dayjs,MS.EJB.,R^
Prpteil, M.D. aixd

Eleetrosurgieal TreatnjCTt of
ExpCTtrnental Bleediiig Canine
i&fiuaric Ulcers: Devejojpment
and testing of a compirter
control and ^ better electrode

Tt,lJ! /*t, / J O

Charles F. Morrisoji,

Jr.

jc^ecirosurgivdJ jrisiruxnenr

.14

06/0^/78

iJS4^0^,^86

Max Scbneidei^

JCpt)^^ Output
Electrosurgical Unit

15

0mm

US4vIJ6^r?8and
its ffle history

Ebeihard Roos

Etectrb-Stirgical Device

16

11/00/79

Digestive
Diseases: and
Sciences, Vol, 24,
No, li;,i45-«48

M.li- Deimi^ J ,
Peo(>les/R. HU^
DC. Auth, RL.
Prdtell,C^,Kul)in,
and F,E: Sily^rstefii

Evdiution of Ele^ttroM
i n Control of Bleeding of
Es^rimehtiaJ Oastric Xjkers

#

Jssue/
Pub'n
Date-

Patent Number/
Publjcatipn

Inventpr/Author

Title

17

01/01/80

US 4,181,131

HisaoOgiu

High hrequency
Electrosur^eal Instrument for
Cutting Human Body Cavity
Structures

18

omi/m

US 4,184,492

Hains H. Meinke^
Gerhiard

Flaehenecker, Karl

Fasteimicier,

Friedrieh

L^distdrfer, Heinz

Safety Circuitry for High
Krequeney Cuttipg and
Coagulating Devices

19

ll/il/80

US 4,232,676

Siirgical Gtitting Lastiiimra^

20

02/03/81

US 4,248,231

AS^dtew H axid
JmnesAv Murphy

Surgical Cutting Instrument

21

02/00/82

CRC Press,

American Wf^rt
Jounial, Vol. 117,
332-341

Kevin J. Barry, M$,
Jpnaftan Kaplan,
Kii>i RiiX*^ond I.
Cdndnbliyi :^D, Paul

Bbijaii^

MD, Giary J. Beckerv
MDi^Brufee:*. Waiief,

The effeet of radiofirequency-
generated thermal energy on
ine mecnamcai and Justpiogic
characf eristics of the arterial
wall in vivo* lfTmlication"5 for
radiofrecj^uency angioplasty

22

US4326;529

llibliai^j^

Gpmeal-Shaping Electrode

23

US 4,381,007

JaiiiesJDfi.p©sS:

MuJtipgtjOT
Elex:t3f pde Awtlj
RemoyayeSi^^^

24

00/00/84

Gufi25, 1424-
1431

jU R ..

Lewin^ XS^ GItRon,
f.C Nortfifield; PJ3.
Cottbh, and P jl.
Salmon

WhiGhee<^iDKJe?A
com^arisdh of four ^doscdpic
methods 6f electrPeoagiiiaiti^^
in experimental bleeding iilce^

3

u

Jssue/
Pub'n
Date

Patent Number/
Publication

Inventor/Author

Title

25

00/00/85

Urological
Research 13:99-
102

J.W.A. Kamsay^N.A.
Shepherd, M. Butler,
PT. Gosling, R.A.
Miller, D.M.A.
Wallace, H>I.
Whitfield

A Comparison of Bipolar and
Monopolar Diathermy Probes
in Experimental Animals

26

06/00/85

JACC VoI.5,No.
6,1382-6

Cornells J. blager,
MSg, Catharina E.
Essed, MD, Johan
CH* SGhuurbiers,
BSb, Nicolaas Bom,
Ph.P, Patrick W:
Serruys, VS), Geert
T. Meester,MD,
FACC

VanoriViitfoti of*

Atherosclerotic Plaques by
S|)£iifcEjo

27

10/22/85

US 4,548^07

Harry G. Reimels;

Di^^able Coagulator

28

05/27/86

US 4,590,934

Jerry L. Mails,
IjeOoard i; M
Robert R. Acorcey,
David Solt

BipHalar Gutter/Coagulator

29

A A /AA yOT

00/00/87

Kardiolpgie,
KaidipL76: Supj).
6, 67-71 (1987)

(j J SJaeer Ail
Phai G.E Esse^^
IX,H. Sehuirrbiers,
N. Bom, V,A.
Vayridenbrotteke^ and
PW^Semiys

Sparic&osion of
Arteriosclerotic Plaques

30

04/28/87

US 4,660,571

Stanley K. Hess,
T^iTi koVacs ^

l^erGutariebus Lead Having
R4^diailtv AdiiD^Sitab Electrode

m '■

06/23/87

US4,674,499

David S C. Pao

07/00/88

Valkvl^ l^ait

Number945 lOO
102 A

Valleylab, Inc.

Surgistat Service Manual

33

1 1/22/88

US 4,785^823

ghilip E. Eggers,
R<)bert F. Shaw

Methods An^ Apparatus For
Peifi^^ Vivo Blood
Th^iitiipdiiu Procedures

34

00/00/89

SFlJh; VoJ. 1 068

Catheler-based

SCTsiiigOTd

ImagiDg

Technology

PaulCNardella

Radio Ef^iU^ihcy Energy and

4

»

Issue/
Pub'n
Date

Patent Number/
Publication

Inventor/Author

Title

35

00/00/89

J he Organizing
Cominittee of the
7* World
Congress on
Endouroloev and
ESWL

Foundation for
Advancement of
Ihternatibnal
Sciience

Robert Tiiokpr and
Stefan Loening

Loop

36:

US4v805,6l6:

David S C Pao

Bipolar Frpbes lor Uphthalmic
Siif gery and Me&ods of
Peifdrifriing Anterior

. V^PvM40vviny

37

03/00/89

Journal of
Urology Vol.
141,662-665

KoBejrt JD. J uckeiri^
Eiigent V,
K^amojowsjcy, iEric
Bedell and Charles E;
Platz

A Comparison of Urologic
Applicatibh qf fiipQlz^ Versus
lVloj>Ppolar Five French
Eiectrpswgical Probes

JO

JACC VoL 13
1^0.5,1167-75

Benjamin 1. Lee,
MD,FAGC,G^Jv
Becker, MD^ Bruce
F. Waller, MD,
FAGCkevinJ,
jaarij^.mo, ivayHipuO

JonaitL^ K^lao,
Mp,AlaBR:.
SliajpirOi MS, Patii C.
>iaHeiia,BS

Thefmal Compression and
Molding of Atherosclerotic
Vascular TissiUe \yith Use of
R£Uh6f^^ii6il^^ Eiifergy i
ihipiicatipns for
Radiofrequency Balloon
Angioplasty

39

04/25/89

US 4 8^3 791

ippinipick

Pet^xi2zi, Robert H-
Quint

Hectrpsurgical Probe
Apparatus

40

05/23/89

US4,832»(H$

jPlpiialiil Ccihen

Suction Ablation Catheter

41

00/00/90

Jroidgieaj
ReseaitJj iS::291-
294

KJD. Tucker, EV,
l&sunjplpwskyi and
C.E. Plate

In VI vo iehect ot 5 French
bijxilar and inoAPpptdr-
etectfosurgical probes on the
porcine bladder

5

Issue/
Pub'n
Date

Patent Number/
Publication

Inventor/Autbor

Title

47

yX/ UV// >rv/

jQurna] of

T Trnlricrv A/nl

143,275-277

Eugene V.
ivninioiowsKy ana
Robert D. Tucker

Use ol 5h Bipolar
Electrbsurgical Probe in
Endoscopic Urblogiical
Procedures

43

04/05/90

WO 90/03 152

John Considihe, John

tJectro-surgical Apparatus tor
Removing Tumours from
Hollow Organs of the Body

44

05/01/90

US4,920,978

David P. Colvin

Method and Apparatus lor the
iEndoscopic Treatment of Deep
Tumors IJsingRjF
Hyp^rtherniia

45

06/05/90

US 4,93 1,047

AJm broadwin,
Charles Vas^allo,
Joseph Nw Lpgm,
Rdb^xt W. HGrnlein

Method and Apparatus hor
Providing Eiihtoceid Tissue
Fragmentation And/Or
Hempslasis

r eicr piasz

Ul tirasonically Enhanced RF
Ablation Catheter

Hi

lu/iu/yo

Uo 4i!/oopy.7

Enc R. Gosman

1 hemometne Cil^diac 1 issue
Ablation Electrode with Ultra-
Sensitive Temperature
Detection

48

12/11/90

08 4,976,711

David J, Fan ns, Mark
A. Rydell, Peter
Stasz

Ablation Cameter With
Selectiyely Deployable
Electrodes

Uo 'I, y /y,5'»i 6

IjesisUe A. (Jeddes,
IS^arviii Hindsi Joe
% Bptirland, William
p. Vporbees

Method arid Apparatus for
jnermally Destroying A Layer
of An Oi^an

50

DE 3930451 Al '

Jbllen ilotti^^
GerhardySteini^

VpiTichtung lyr die
Hochfi-equ^nzkoagulatibn von
biblogischejm GevVejbe

51

04/16/91

US 5,007,90$

Mark A.Rydeli

tlect^osurgical ii^^
Haying Ne^Sle^^C^
Electrode And Spot-Gpag
Electrode

52

04/23/91

US 5,009,656

Harry Kei^^^^^

Bipolar Electrosurgical
Instrument

53

Q7/30/91

US 5,035,696

Mark Av Rydell

tiJectrosm-gicaJ instniment tor
Conducting Endoscopic
Retrograde Sphihcterotoiiiy

6

Issue/
Pub'ii
Date

Patent Niimber/
Pablicatioh

Inventor/Autiior

Title

54

09/00/91

Journal ot
Urology Vol.
146, 669

tugene V.
Kramolowsky and
Robert D; Tucker

The Urological- Application of
Electrosurgery

55

09/10/91

US 5,047,026

Miark A. Rydell

Electrpsurgical Implement For
Tunneling Through Tiissue

56

09/10/91

US 5,047,027

Mark A. Rydell

Tumor Resector

57

10/07/91

bipolar
Laparpscopic
Gholecystiectoiny
Lecture

Dr. Olson

Bipolar LapairbscopiG
ChpfecysleiGtbmy

58

0J/i4/92

US5>08O,66O

Texrerice J. Buelna

Electr<ysurgical Electrode

59

01/28/92

US 5,084,044

Robert H: Quint

Apparatus tor

Ahlatiipn and Method of tJsing

60

(G/04/92

US 5-085,659

Marie A. Rydell

Biopsy Device With Bipolar

. Vif'V/a^lll all \Ji J vxlJAx UlXl IV

61

02/18/92

US5,088;997

LOUIS U'eiahiierga,
Jiobert B. Stocidiard,
MiehaelS. Klicek

Gas Coagulation Device

62

US 5,098,431

Mark A. Rydell

RF Ablatfon Catheter

63

US 5,108,391

Fl^cheriecker, Karl
Fastenniei ier , Heinz

^ol^^rF^c^ucui>y vJviicratQr ror
TiSstfe Cutting And For
Ciftaoiiliatiri'fr Tri Hiph^
Ft^uenc^y Surgeiy

64

05/12/92

US 5,112,330

ResectbSGope Apparatus

6S

06/1^;

US5,122,138

Kirii H, Ma3i\v^iTi3ig

Tisisiie Vapprizin

:#ind wfptHivi fnr an* F^nHrto^^An^-

66

12/01/92

US 5,167,659

Mapki Qbtpmo;
Shizuioi Ninpmiya

Blood Coagulating Apparatus

67

12/15/92

US 5,1 7U 11

MarK A, KJqeil,
David J. Parins,
Sfeven W. Bierhow

Texicutane^ l^I^QSCopic
vChblipfetfectpmy Instrument

68

03/30/93

US 5,1 97,963

David J, Parijls

iiJectrosurgical instrument with

j&ctend^^^ for
Inig^tipn asid^A

69;

05/04/93

US 5,207,675

Jerome (Eariady

Siu^oal Coagulalioh Device

7

Issue/
Piib'n
Date

Patent Number/
Publication

Inventor/Author

Title

70

06/08/93

US 5,217,459

William Karnerlmg

Method and Jnsitument ibr
Perfonntng Eye Surgery

71

04/26/94

US 5,306,238

Richard P. Fleenor

Laparoscoipic EleGtrosurgical
Pericil

72

06/13/95

US 5,423,882

Warren jyi. Jackmari,
Wilton W. Webster,
Jr.

Uiatheter Having: tlectrode
With Annular Recess iand
Method of Using Sarnie

73

10/03/95

US 5,454,809

Michael Janssen

ItleGtrosurgical Catheter And
Method For Resblving
Artheroisclenijic Pla^tie By
Radio Frequency Sparis^

1. vs. Patent No. 5,697^36 C^the «S36 patebt^)
A. Giaim 45

Sjmitb & Nephevir cbntenids that elaiiai 45 of th6 *S36 patent is anticipated by at
least eaeh of the following references: 3, 8. 12, 15i 16, 18, 19, 20, 21, 212, 23, 24, 25, 26,
33, 35, 36, 37, 38,41, 42, 43,45, 46, 48, 49, 51, 52^53v 54, 57, 61, 63^ 65,
66, 67, 69, 70, 71.

Sniith & JNbphew also contends that claiin 45 of the; -53 6 patent vvould have beesri
obvious to one ofordin?ury skill inthe art at the tiihe of the inventibri in view of at least
itaGb of tbe feWo cbiiibiiiattons bf^r^eretic^^x^ Nephew eontendS

WbUld have beeW ^iiiibin^^

Upinbinall^ii

Any one or more ot 4^ 5, 5, 7, lU, 11,
13, 16, 17,20, 30, 33, 39,40,44, 50, 55,
56, 58,^0,^1, 62,^, 68, 69, 7i, 72, 73
ywUi My one br moT^^ 54» 57.

E^cfi iefCTfeijt^ is dir^ to the same
target s^ite on a patients structure.

Any pneor moreol 1, 4, 6,6, 7, 9, 10, 1 U
13,16, 17,20, 30,33, 39, 40,44, 50; 55,
56, 58, 60,^1 , 62, 64, 68^ 69, 71, 72, 73
wi th any other bjne or mOrfe of the
antieij^atiiig refej^c^^^^^

jp^ibfele^^^ ppjfrfyitiig eleeW^ (energy to a
target site on a j^denrs body structure:

8

CombinatioD

Motivation to Combine

Any One or more of 35, 54, 57 with 59.

tach relerenee is directed to the same
problem - applying electrical energy to a
target site on a patient's body structure.

Ariv one or more ol 33* 54^ !>7 vinth iahv
Other Qjie or more of the antieipating
referenees listed above.

problem - applying electrical energy to a
target site on a patient*s body structure.

Any one or more ol 2, 34, 4 / with any one
or more of the aiitidpaling references listed
abfove.

Hach reference is directed to the <;ame
problem - applying electrieal energy to 3:
target sit^ on a patient's body structure.

59 with any one or more of the antidpatihg
references listed iabove.

tach reterence is directed to the same
problem - applying electrical :energy to a
target site on a p^Uent's bp^

2. U S. Patent No. 5i697^82^th^ 882 patent")

A» Claim 1

Smith & Nephew ccHiteftds thM clai^^ \ of the '882 patent is anticips^^^^^ least
eachipf the following references: 2, 3^ 5^ 8, 1 5, 16, 18, 22, 2S, 24, 25^ 26, 27, 28, 29, 30,
3a, 34, 35, 36, 37, 38, 42, 45, 46, 48, 49, 51, 52, 53, 54, 55, 57, 61, 62, 63, 65, 66, 67, 68,
71, 73.

Smith & Nephew als^ contefii^ that daim 1 of (he '882 p^atfent have been
#vious to one of ordinary skill in the aft at the time of the iilventi^ni^^^^v^^^^ pf at least
each off the followiig combinaitibti^^^ which Smith^& Nephew contends

>vpuld jhave been combing for atleast A^ fpUoAying reasons:

CoIIlj[>l^aation

MPttvation 16

Ai^^e or^ore ot 1 , \ ^ tci^ 30,
% 44 44, 47, SQ, 55, 56. 58, 61^62^64,
68, 69V 71, 73 witii any olher om or more
pi^tfiefitotidpating references ]i:sted:ai>py€

Each teferenteris diijecte^ to same
problem ^ applying el^^^^^^^ a
target site cm a pafi6hi-S "felMy

9

Cofubination

Motivation to Combine

AJiy one or more ot 1, 5, /, i^, 1 1^ 17, JU,
39, 40, 44, 47, 50, 55, 56, 58, 61 , 62, 64,
68, 69, 71 , 73 witfi My brie or more of 2, 3,
4, 12, 16, 18> 21, 22; 23, 24, 25, 27, 28, 31,
33, 34, 35, 36, 37, 41. 42, 43, 45, 46, 48,
49, 51, 53, 54, 57, 60, 63, 66, 6?, 70, 72
and with any one or inpre of 1 0, 13.

Eiach reference is directed to the same
problem - applying electrical energy to a
target site oh a psitient's body structure.

Any one or more 012^5,4, 12, 16, 18,21,
22, 23, 24, 25, 27, 28, 31, 33, 34, 35, 36,
37, 41, 42, 43, 45, 46^48, 49, 51, 53, 54,
57> 60, 63, 66, 67^ 70, 72 with ^y other
one ormoiie of theariticijpmti^^
listedabove.

Each reference is directed to the same
problem --appl^dn energy to a
target site on apaiient*s body strijcture.

AJiy one or more 01 2^ 3^ 4i i^, ib, J 8,^J,
22, 23, 24, 25, 27, 28, 3M3> 34, 35, 36,
37, 41, 42, 43, 45, 4^ 48, 49, 51 , 53, 54,
57, 6Q, 63, 66, (57, 70, 72 vrith any one or
raoreoflCf, 13.

Each iref^l^^

probleni " ajpplyin^^ energy: to a
target site on a patient*s body structure.

Airy one or more ot lu, j j vwth any other
one or more of the an%ipating references
listed above.

liach rete^iic to the same
prpbliem;-;a^^ enis*gy1o a
targfei $He Oil! a pati^eiif s tody $t^

Smith & N^eWiiimher M 1 of the^ '882:patent is also invalMas

indefinite under 35 U:SJS. § 1 12: H 2.
B. Claiiiii2i$

Smith & Hepi^y^ tont)^^ claim 26 of the '^8^2 p^aterit i^^a^^ by at
least each dfthefblldvv^ references: 2, 5, 23, 26, 2^, eii

Smith & Nepbe^ also tpi^tends that ^mm Qfthe ^$82 patqii wpuld have b^ati
obvious to one df brditi

each of the following combinations of references, whith^
ivoiild have been wmbiried for at least the following reasons:

10

Combination

Motivation tof Combine

Any one or more ol 1 , 6, /, J 0, 11, 1 3, 1 7,
-aOi 39; 40, 44, 47, 50, 55^ 56, 5%62, 64,
68, 69, 71, 73 with any pnie or lijdrie of 3, 4,
8, 12, J5, 16, 18, 21, 22. 23, 24,25, 27, 28,
31 . 33, 34, 35, 36, 37; 38, 41 , 42, 43, 45,
46, 48, 49, 5 1 , 52, 53, 54, 57, 6Q,^65, 66,
67, 70, 72 and with any one or more of .9
14,32,61.

Each reference is dir^ected to the same
problem - appl)dng dectoic^ energy to a
target site on a patient's tKkly slructure.

Any one or iiiore ot 1,6, JU, I J , 13, 17,
30, 39, 40, 44, 47, 50. 55, 56, 58, 62, 64,
.68-, 69, 71, 73 with any one or inOre of the.
^anticipating xeferences listed above.

Each reference is directed to the same
problem - applying eliectdcal energy to a
target site on a patient's bwpdy slructo

Aniy one or more pi 3, 4, 8, 1 Z,. 1 5.. 1 6, 1 8,
21 ,22, 24, 25, 27, 28, 31. 33, 34, 15-36;
37, 38, 41 , 42i 43, 45, 46,48^ 49, 51^52;
53, 54, 57, 60, 65, 66, 67, 70, 72 with any
one or meat 6f % 1 4, 32, 61.

JEath referencie Is dii^ed to the ^me
^^ri)b]te^ eher^ to. a
target site on a t><afi^t^^l^^

/Mij viK or uiure ui j, t, o, iz, 13, to, l o,

21, 22, 24, 25, 27, 28, 31, 33,M,^,36,
37, 33, 41 , 42, 431, 45, 46, 4^.45*^51, 52;
53, 54, 57, 60, 65^ 66, 67, 7i)itPvMi^saxy^
one or indre^ of the antidpating refbreoces

Each jrefe^ence is direct to t6e same
jirdblena — applying elecMc^ energy to a
girget: site on a patient *s body stnicture.

JKny ont pjm^ J4, :iii,61 ^tfla^
one or more pf the anticipating refeteiM:^^^^
listed ^teve.

Jb^Ctt^retittence 15^^^

|>feblerii-- app enej^to a

tia^giet on a p^tient's^it^ stnictur6.

Sxiiith & N<|phe^ fnrther coiiteiids th^^^ '882 patfeiit is also invalid

as it3dfe%ite under 35
C. Claim is

Smith & NepbewGontend$ t^ ^ of tfafe 'Ml patent^is antj^^t^ hy M
least each of the follovdng refereirces: 8, 15^ 21 , 26, 2% 41, 42, 45, 57.

Smith & Nephew also cQrit^ds that clafim 28 of the '882 patent would have been
pbyioiK b one of ordinary skill in the art at the titne of the inveint jpn in view of at least
each of the foliowing combinations of references, which Smith & Nephew contend^
would have bem cpmbmed for at kast the fpllpwjng reasons:

11

Combination

Motivation to Combine

Any one or more ol 1 , 6, /, y, 10, 11,13,
1 7, 30, 39, 40, 47, 5Q, 55, 56, 58, 62, 64,
68, 69, 71 , 73 with any one or more of 2, 3,
4, 5, 12, 16, 18, 19, 20, 22, 23, 24, 25, 27,
28, 31, 33/34, 35, 36, J7, 38, 43, 46,48,
49, 51, 52, 53, 54, 60, 63, 65, 66, 67, 70, 72
and with any one or inore of 44, 61.

Each reference is directed to the same
prbblem ^ appl)nrig electrical energy to a
target site on a patient's body structure.

Any one or more ot 1 , 6, 7, 9, 10, 11, 1 3,
17, 30, 39, 40, 47, 50, 55, 56, 58, 62, 64,
68, 69i 71 , 73 wi th ainy one or morfe of the
Mticip^ting references listed above.

Each reference is directed to the same
problem— applying electrical energy to a
target site on a patient* s bi^dy structure;

Any one or more 01 2, 3, 4* X 12. 16* Ji$.
19, 20, 22, 23, 24, 2S, 27, 28, 31, 33.34,
35,36, 37, 38, 43, 46, 48,49, 51; 52, 53,
54i 60, 63, 64 66, 6% 70, 72 S^tfeaa^ qrie
<jt more of the itnticipatjinig re^
above;

Each referaice i$vdir

jprbblern -^pl^ng tl^^ energy to a

target site on a patie^^ structure.

iiny piie or more ot 2, 3, 4, \ 12, 16, }»,
19, 20, 22. 23, 24,25. 27, 28, 31. 33, 34,
35,36,37, 38,43,46, 48,49,51, 521,53,
54, 60, 63, 65, 66, 67, 70, 72 with any one
or mbre of 44, 61.

Each refeTence is ifi^^ to the same
ijroblfeni — aoDlvinfi: electtri cal enerev to a
target site on a patrent's l)^ structure;

Any one or more ol 44, 61 with any one or

niprepf jfte aritid

abftve.

tiach reterence is directed to the sam^
problem -- applyiiig d energy to a
target site . pn a patieM;S^^^^ structure.

Smith & Nephew ffcirther contends that claim 28 of the * 882 patent is also invalid
a$ indefinite under 35 IJ.S.C. § im^±
tl>S. Pat^il^i». $yi^t4i^
A. Chiml

Smith & l^ephew contends that 1 of the '592 patent is anticipated by at least
each of the followpgreferenGes: 15, 23, 26,30, 31,33, 34, 46^ 4«^ 51, 52, 62, 72.

Smith & Nephew also contends that claim 1 of the *592 patent would have been
ObvibuS to one pfordiriary skill in the art at the time of the iiiventiori b view of at least

12

each of the following combinations of references, which Smith & Nephew contends

would have been combined for at least the foIlo\ving reasons:

Combination

MblivalioD to Combine

Any one or more ol 1^ 5, 7, J U, 1 1, J 3y
17, 30, 39, 40, 44, 47, 50, 55, 56, 58, 62,
64, 68, 69, 7 1, 73 vrith any one or more of
me ouier anucipaiuig xeiereijces MSieQ
above.

Each reference is directed to the same
problem — applying ielectrica^ energy to a
target site oii a. patient's body structure.

Aiiy one or more ol U 6, 7, 9, 10, 11, 13,
17, 30, 39,40, 44, 47, 50, 55, 56, 58^ 6!2,
64, 68, 69j 71> 73 wifli^any one or mcffe of
2, 3, 4, 5, 12, 16, 3 8, 20-^, 22, 24; 25,. 27,
7^ 70 Ti l '^d ih "xsi At /to

43, 45, 49, 53, 54, 57^ 60, 61;^^ 65, 66,
67^^ 70, 72 and with any one or niore pf the
other anticipating reftieneiss li^ed-al^yel

Each referferi^ to the same
piiobleani^^^^^ ic^nergy to a
target; $ite oh a patient'si body structure.

Any one or more ol2, 3, 4,^i 12^ 1 6, 18,
20, 21, 22, 24,55, 27, S8i 29, 31, 33, 34,
35, 36, 37, 38, 41, 42, 43-45, 49, 53, 54,
57/60,^! ,63, 65v66^ ^^70, 72 wMi^y
on0 ore more of the other anticipating
refejfences listed ^bove.

Eackifeferettce i ditarted to the sarqe
problern - agp^dng elec^'cal energy to a;
target sitie on a patient *^s body stnieture

Smith & Nephew^^i^^ contends th^^^ claim I of th^ *592 intent is also mvalid ias
indefinite under 3S U.SvC § 1 12^ 2,
B. Claim 2!gi

Smith & T^phew cpmwds th^^ <tf the Extent is^^a^ at

km:€Mi omtm^^ 15, 26, 30^ j%4i,^

Smith & Nephew ^sp coiiti^^ ciaixn 23 of tbe *592 patent woiild have been
obvious to one of ordinary sldll in the art at the time of theihvention in vieTiv of at least
each of thefollbwiiig combinafipns of referientesi which contends
wQuld have been combked fo^ at least the fQllovrihg rea^^

13

Combination

Motivation to Combine

Any one or more ol 4, 5, 12, 16,24, 25; 31,
36, 37, 38, 41, 42, 53, 61, 63, 65, 66, 67,
70, 72 with any one or more of the other
antiGipating references listed above.

Each reference is directed to the same
problem - appjying electrical energy to a
target site on a patient's body structure.

Any one Or more pi 2, 3, 1 », 1 y, 2U, 2 1, 22,
23, 27, 28, 29, 33, 34, 35, 43, 45, 49, 52,
54^ 57, 60 with any one or more of the
other anticipating references listed above.

Each reference is directed to the same
problem - applying electrical energy to a
target site on a patient*s body structure.

Any one or more 012, 3, 18, 19^ 20,21, 22,
23, 27, 28, 29, 33, 34, 35, 43, 45^ 49, 52,
54, 57, 60 with any one or more of 1 , 7, 1 0,
17j 44, 55, 56 and any one prmdre of Uie
pjher anti^^^ listed ibPVe,

Each reference is directed to the same
problem - applying electrical energy to a
target site on a patierit^s body -structure

; Any one or more Ot 2, 3, 18, 19, 20, 21, 22,
M 21^, 2«vj^, 33; 34, 35, 43, 45^ 49, 52,
54^ 57^ 60 \yith 59 and any one or more df
the Other anticipating references listed
above.

j^ch reference is directed to

problem; applying electrical ene^ a

tfiffget site on a patient 's body strud^

Any one or more ol 1, 7, 11); 17, 44, bt>^ 5b
widi any Pne OT m Oire of the oj^
aotfeipaitp^^ listed ahoye.

liach relerence is directed to the same
pi^bleih appilyihg^^e^ energy to a
t^etisit^! pn^^^ fe^'Stru^te

An3^<)heorTOoreQt6,9, 11, 13,30,^i>^40,
47^ 50, 58, 62, 64, 68, 69, 71, 73 \vith any
pnc; or m0^^e of the other anlieipaling

Each feferCT^

jjjjrPblem applying declrical^^^ to a
target site on a p bK>dy stitid^

Any OT^ Pr lijc^ ol 6, 9, 1 1 ,13, 30, 39, 40,
47; 50, 5$i 62, 64, 68, 69, 71, ^ with 59
and any pne or more of the other
mitieipating refe^^ above.

Each referenep: is directed to%e:saixi
problem applying elettricd^^ a
i^get site Oil apatient's bpdy structure.

^ v!?itha?iy oiie^o^^

anticipating references listed above.

i^ch relerence IS directed 1p the saafhe
prpfelem ^eetricsfl eifergy to a
target

4. AMi^Patents

Smiib &■ N^^phew also Gomehd^ thfe assayed tlai^^ of flie '536, -882 arid
'592 patents are also invalid under 35 U.S;G. § 102(f) and/or §116 beeanse of impro0r
inventorship?,

Sitfith & Nephew's in vetsti^^^^ iscpntmmng, and it reserves

the right to assert additional invalidity defenses as discovery progresses.

14

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